Product Quality Management Associate mfx

As an important part of a small team you will have the opportunity to support our company on its way to quality excellence. Through your meticulous and accurate way of working you will own the product documentation structure and you will be responsible for creating comprehensive and understandable documentation. In your role you will form an essential interface between all teams.

Ideally you have already gained practical experience in the pharmaceutical industry or in the manufacture of medical devices and can contribute your knowledge from this area or bring a quality management background within a product company.

Tasks

• Own the product & validation documentation and collaborate with Engineering Quality Assurance and Product Owners in order to ensure they meet regulatory and company standards
• Build up and structure product documentation in accordance to our quality management system and ensure different level of details for internal and external use
• Providing support to quality management such as report preparation and project coordination
• Coordination of Change Control Activities by ensuring availability of documentation (e.g.: Release packages)
• Assisting in the investigation of nonconformities to support root cause analysis activities
• Participating in continuous improvement initiatives for our internal processes

Requirements

• Excellent written and verbal communication skills for ensuring clarity and coherence in all documentation and to collaborate effectively with various teams
• The ability to efficiently organize and maintain large volumes of documents ensuring they are easily retrievable and systematically filed
• Demonstrates a keen eye for identifying and resolving quality deviations with a strong focus on preventing future occurrences through proactive measures and continuous improvement initiatives
• The ability to analyze quality data identify trends and translate insights into actionable improvements
• Ability to translate complex concepts into clear actionable plans and documentation

NICE TO HAVE

• Technical or engineering education / studies preferrable with experience in software development processes
• Practical experience in the relevant industries (Pharma Medical devices Software development)
• Knowledge of relevant industry standards and regulations (e.g. EUGMP) to ensure consistent adherence
• KnowHow of Knowledge Management and / or Quality Management Tools (e.g.: Confluence eQMS CAQ)
• A deep understanding of quality management principles methodologies (e.g. ISO 9001) and best practices

Benefits

• A minimum gross salary of 45.000 per year (excl. bonus) overpayment possible
• Flexible working time and the possibility to work from home
• Permanent fulltime contract (385 h / week)
• A modern office in Innsbruck in the middle of the Alps
• Starting date as soon as possible
• Mobility package (1year ticket for public transport in Tyrol or a parking space near the office)
• Free English courses with your team colleagues